Open-label evaluation of the efficacy and safety of etanercept in rheumatoid arthritis

Abstract

Objective: In this open label Phase IIIb study, the safety and efficacy of Etanercept in Indian patients with Rheumatoid arthritis was assessed in 4 centres across the country. Patients and Methods: Forty patients who fulfilled the ACR criteria of RA and had active disease despite at least one disease modifying anti rheumatic drug(DMARD) therapy were administered Etanercept (Wyeth) 25 mg subcutaneously twice a week for a 16 week period. The primary outcome measures were proportion of patients achieving ACR 20 response at 16 weeks. Secondary outcome measures were proportion of patients achieving ACR 50 and 70 response, improvement of morning stiffness, tender and swollen joint score at 4, 8,12 and 16 weeks. Quality of life assessed by the Health Assessment Questionnaire and Shore-Form Health Survey. Intent to treat analysis was done and adverse events were noted. Results: Seventy percent achieved ACR 20 response at the end of 16 weeks. This was statistically significant as compares to baseline and improvement at 4 and 8 weeks of 25% and 57.5% respectively. The proportion of patients achieving 50% and 70% improvement were 42.5% and 17.5% at 16 weeks respectively. The HAQ decreased from 1.89± at baseline to 1.00(±0.673) at week 16. The Short Form-36 Health Survey assessment found that the mean scores of all aspects of this measure of patient physical and mental functioning improved from baseline. The domains most affected by Etanerept treatment were role function as limited by physical problems (mean change from baseline at week 16, 46.9±46.75) and role function as limited by emotional problems (mean change from baseline at week 16, 475±51.69). Conclusion: The data from this study population have shown Etanercept to be efficacious and well tolerated drug in Indian patients with RA.